US2024390693A1PendingUtilityA1

Conductive spacer in an electrode assembly of an electrical treatment apparatus

Assignee: PULSE BIOSCIENCES INCPriority: Apr 13, 2021Filed: Jul 29, 2024Published: Nov 28, 2024
Est. expiryApr 13, 2041(~14.7 yrs left)· nominal 20-yr term from priority
A61N 1/36034A61N 1/36017A61N 1/36014A61N 1/36002A61N 1/0502A61N 1/0476A61B 2018/143A61B 18/14A61N 1/40
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Claims

Abstract

To distribute electrical treatment to a treatment area of a patient, described herein are electrical apparatuses, methods of their operation and methods for delivery of the electrical treatment to the patient. In some embodiments, the treatment applicator comprises an electrode assembly that includes at least two electrodes, and a conductive spacer positioned between the electrodes. Methods of treatment and methods of operation of the apparatuses and systems of the present disclosure are also provided.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An electrode applicator apparatus for treating a tissue, the apparatus comprising:
 a handle;   an elongate body extending distally from the handle;   a tip region extending distally from the elongate body;   a first electrode extending along a first side of the tip region;   a second electrode extending substantially parallel to the first electrode on the first side of the tip region; and   a conductive spacer configured to surround and/or cover at least a portion of the first electrode and the second electrode, wherein the conductive spacer comprises an electrically conductive material configured to have a conductivity that is less than the conductivity of the first electrode and the second electrode.   
     
     
         2 . The apparatus of  claim 1 , wherein the electrically conductive material comprises a polymeric material. 
     
     
         3 . The apparatus of  claim 1 , wherein the electrically conductive material comprises a porous or absorbent material configured to be filled with a conductive fluid. 
     
     
         4 . The apparatus of  claim 1 , wherein the first electrode and the second electrode comprise wire electrodes. 
     
     
         5 . The apparatus of  claim 1 , wherein the first side is a tissue facing side and the conductive spacer covers a back surface of the first electrode facing the back side of the tip region which is opposite to the first side of the tip region. 
     
     
         6 . The apparatus of  claim 1 , wherein the first electrode and the second electrode extend along a longitudinal length of the first side of the tip region. 
     
     
         7 . The apparatus of  claim 1 , wherein the first electrode and the second electrode extend proud of the first side of the tip region. 
     
     
         8 . The apparatus of  claim 1 , wherein the first electrode and the second electrode are flush with the first side of the tip region. 
     
     
         9 . The apparatus of  claim 1 , wherein the first electrode and the second electrode are configured to pass electrical pulses having an amplitude of at least 0.1 kV therebetween. 
     
     
         10 . The apparatus of  claim 1 , wherein the conductive spacer comprise a first and a second conductive spacers. 
     
     
         11 . The apparatus of  claim 10 , wherein the first and the second conductive spacers are separated by a blocker. 
     
     
         12 . The apparatus of  claim 1 , wherein the conductive spacer comprises a plurality of gaps or pores configured to be filled with a filler material to set the conductivity of the conductive spacer. 
     
     
         13 . The apparatus of  claim 1 , wherein the first electrode and the second electrode are separated by a fixed distance. 
     
     
         14 . The apparatus of  claim 1 , wherein the conductive spacer has a conductivity that is between 0.01 S/m and 5 S/m. 
     
     
         15 . The apparatus of  claim 1 , further comprising one or more fluid ports in fluid communication with the conductive spacer. 
     
     
         16 . The apparatus of  claim 1 , wherein the tip region comprises a paddle region. 
     
     
         17 . The apparatus of  claim 1 , wherein the conductive spacer comprises a sponge material configured to be filled with a saline. 
     
     
         18 . An electrode applicator apparatus for treating a tissue, the apparatus comprising:
 a handle;   an elongate body extending distally from the handle;   a tip region extending distally from the elongate body;   a first electrode extending along a first side of the tip region;   a second electrode extending parallel to the first electrode on the first side of the tip region; and   a conductive spacer comprising a sponge material filled or configured to be filled with a conductive fluid, the conductive spacer at least partially surrounding at least a portion of the first electrode and the second electrode, wherein the sponge material together with the conductive fluid achieve a conductivity of the conductive spacer that is less than the conductivity of the first electrode and the second electrode.   
     
     
         19 . A method of treating a tissue, the method comprising:
 applying a tip region of an electrode applicator against the tissue so that a first electrode, a second electrode, and a conductive spacer of the electrode applicator are in contact with the tissue, wherein the first electrode and the second electrode extend longitudinally along a first face of the tip region, further wherein the conductive spacer at least partially surrounds the first electrode and the second electrode; and   applying a pulsed electrical energy between the first and second electrodes to generate an electric field to treat the tissue, wherein the conductive spacer modifies a depth of the electric field in the tissue.   
     
     
         20 . The method of  claim 19 , further comprising wetting the conductive spacer with saline before applying the tip region against the tissue. 
     
     
         21 . The method of  claim 19 , wherein applying the tip region against the tissue comprises compressing the conductive spacer against the tissue, wherein the conductive spacer comprises a sponge material. 
     
     
         22 . The method of  claim 19 , further comprising determining a characteristic of the conductive spacer. 
     
     
         23 . The method of  claim 22 , further comprising identifying electrical treatment parameters based on the characteristic of the conductive spacer. 
     
     
         24 . The method of  claim 19 , wherein applying the tip region against the tissue to be treated comprises applying the tip region against a cardiac tissue. 
     
     
         25 . The method of  claim 19 , further comprising applying saline to the conductive spacer while applying the pulsed electrical energy. 
     
     
         26 . The method of  claim 19 , wherein applying the pulsed electrical energy comprises applying a plurality of electrical pulses having an amplitude of greater than 0.1 kV.

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